MAUDE Adverse Event Report: ABBOTT MEDICAL TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-F; Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Model Number	A-TCSE-DF
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One bi-directional, curve d-f, tacticath sensor enabled contact force ablation catheter was received for evaluation.Microscopic inspection of the shaft material revealed that the braiding was protruding through the fracture.No contact force was displayed when the returned device was connected to the tactisys quartz unit.A thermocouple signal loss error and optical signal loss error were displayed, and optical fiber 2 no longer met specifications for optical properties.The deformable body thermocouple (tc2) read as an open circuit during electrical testing, consistent with the observed thermocouple error message.Further investigation revealed that the catheter shaft material had been fractured distal to the pull ring.Optical fiber 2 and the deformable body thermocouple (tc2) wires were determined to be fractured at the location of the fracture in the shaft material, consistent with the observed error messages, the detected open circuit, and the reported event.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.
Event or Problem Description
This report is to advise of a fracture found in the catheter tip with protruding components during investigation.During the svt procedure, it was noted that the contact force was not displayed accurately.The contact force was reset; however, the issue persisted.The ensite system displayed an error message stating that no contact force was available.The connections were checked and the tactisys was restarted with no resolution.The catheter was exchanged, and the procedure was completed with no adverse consequences to the patient.

• Brand Name: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-F
• Common Device Name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
• Manufacturer (Section D): ABBOTT MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ABBOTT MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24457873
• Report Number: 3008452825-2026-00090
• Device Sequence Number: 10007253
• Product Code: OAE
• UDI-Device Identifier: 05415067027641
• UDI-Public: (01)05415067027641(10)10762165(17)260831
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: A-TCSE-DF
• Device Catalogue Number: A-TCSE-DF
• Device Lot Number: 10762165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown